Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06442020
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of LiESWT', 'timeFrame': '3 years', 'description': 'To evaluate the impact that the use of low intensity extracorporeal shock waves LiESWT in combination with the early administration of phosphodiesterase 5 inhibitors has on the patient in the process of penile rehabilitation in erectile dysfunction following post-assisted radical prostatectomy robot'}], 'secondaryOutcomes': [{'measure': 'Assess how many patients reach orgasm', 'timeFrame': '3 years', 'description': 'Compare the rate of patients achieving orgasm. The International Index of Erectile Function short form (IIEF-5) questionnaire is the recognized tool for assessing erectile function both before surgery and during follow-up.'}, {'measure': 'Questionnaires of Quality of life', 'timeFrame': '3 years', 'description': 'Compare health-related quality of life outcomes through a validated self-administered questionnaire preoperatively and at postoperative follow-up assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'The study deals with the hypothesis that LiESWT in addition to the administration of PDE5i can improve sexuality rehabilitation with faster recovery of a valid erection and higher IIEF-5 scores in the short and medium-term follow-up.', 'detailedDescription': 'Prospective randomized controlled trial (RCT) designed to provide high level evidences describing the role of Low-intensity Extracorporeal Shock Wave Therapy LiESWT plus early introduction of PDE5i vs early PDE5i alone on penile rehabilitation of erectile dysfunction ED after treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) RARP'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≤75 yrs;\n* Low-risk PCa (PSA \\<10 ng/mL and GS \\<7, ISUP grade 1, and cT1-2a) undergoing nerve sparing RARP;\n* preoperative IIEF-5 score ≥ 17;\n* First PSA (45d after surgery) \\<0.2\n* compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;\n* patients able to provide a written informed consent for the trial.\n\nExclusion Criteria:\n\n* anaesthesiologic contraindications to robotic surgery;\n* patients submitted to pelvic radiotherapy or androgen deprivation;\n* patients reporting major postoperative complications (CD≥3);\n* cardiovascular contraindications to PDE5i medical treatment.'}, 'identificationModule': {'nctId': 'NCT06442020', 'briefTitle': 'Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RS1874/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP 1: LiESWT in association with PDE5i', 'description': 'Therapeutic association between low intensity extracorporeal shock waves LiESWT and the early introduction of the phosphodiesterase 5 inhibitor PDE5i', 'interventionNames': ['Procedure: Tadalafil (PDE5i)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP 2: PDE5i alone', 'description': 'Control group, administration of the phosphodiesterase 5 inhibitor PDE5i, as per clinical practice', 'interventionNames': ['Procedure: Tadalafil (PDE5i)']}], 'interventions': [{'name': 'Tadalafil (PDE5i)', 'type': 'PROCEDURE', 'description': 'Tadalafil at a dose of 5mg/day', 'armGroupLabels': ['GROUP 1: LiESWT in association with PDE5i', 'GROUP 2: PDE5i alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Simone, Doctor', 'role': 'CONTACT', 'email': 'giuseppe.simone@ifo.it', 'phone': '06-5266.5005', 'phoneExt': '+39'}, {'name': 'Riccardo Mastroianni, Doctor', 'role': 'CONTACT', 'email': 'riccardo.mastroianni@ifo.it', 'phone': '06-5266.5005', 'phoneExt': '+39'}], 'facility': '"Regina Elena" National Cancer Institute', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Giuseppe Simone, Doctor', 'role': 'CONTACT', 'email': 'giuseppe.simone@ifo.it', 'phone': '06-5266.5005', 'phoneExt': '+39'}, {'name': 'Riccardo Mastroianni, Doctor', 'role': 'CONTACT', 'email': 'riccardo.mastroianni@ifo.it', 'phone': '06-5266.5005', 'phoneExt': '+39'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}